Published in AIDS Weekly, November 7th, 2005
ReceptoPharm had invited an audit earlier this year in order to identify areas of potential weakness prior to initiating the production of their lead drug products to supply upcoming clinical trials. The E.U. drug production standards are higher than that of the U.S. Food and Drug Administration (FDA), making it essential to have lab certification for support of a clinical trial application. Though not required, the company plans to invite local FDA inspectors...
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